Erica T. Warner, ScD, MPH Harvard School of Public Health & Channing Division of Network Medicine 181 Longwood Ave, 3rd Floor Boston, MA 02115

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1 Erica T. Warner, ScD, MPH Harvard School of Public Health & Channing Division of Network Medicine 181 Longwood Ave, 3rd Floor Boston, MA August 31, 2012 Natalie Pafitis Executive Editor BMC Public Health Dear Ms. Pafitis: Please find enclosed a manuscript entitled: Recruitment and retention of participants in a pragmatic randomized intervention trial at three community health clinics: Results and lessons learned" which I am submitting for exclusive consideration of publication as an article in BMC Public Health. Our manuscript has several important aspects. First, we describe enrollment and retention of predominately low-income minority sample in a randomized weight loss and hypertension intervention trial. The study was set in three community health centers in Boston, MA and there is very little published literature on weight loss and hypertension management trials in this setting. Second, we had very high retention at 24-months, 86.0%, which is important to report and describe the procedures implemented to achieve this level of success. Our findings have implications for future research in with similar populations and in similar settings. We believe it is important to encourage research in community settings with high representations of minorities, since their burden of obesity and obesity related diseases is so high. We think our findings would be of great interest to your readers. Our success shows that conducting longitudinal research in this setting is not impossible even during trying economic and political times. These are populations that disproportionately bear the burden of obesity and chronic disease and are in need of research attention. With dedication, planning, stakeholder engagement, flexibility and sensitivity, high recruitment and retention levels are achievable. Thank you for your consideration of our work. We hope you find it merits publication the BMC Public Health and would welcome any recommendations to improve the work such that it would be a good fit for your journal. Sincerely, Erica T. Warner

2 Figure 1. CONSORT flow diagram Patient Enrollment 0 Settings declined 7 Potential primary care settings 3 Eligible settings 3 Settings participated 4 Settings excluded (no EMR/automated scheduling system) 27,311 adult patients in 3 sites 2564 medical charts reviewed 1540 Excluded 530 BMI <30 or > language a 168 medication(s) b 101 med/psych disease c 95 not approved by PCP 88 no HTN 25 weight loss >5% 138 other exclusion 130 Refused 454 Never reached 2631 Potentially eligible identified through medical records or referral 507 Completed phone screening Randomized (n=365) 860 intro letters mailed 4197 screening calls made 109 Missed appointment 33 Excluded 28 No HTN medications 5 Measured BMI < 30 Allocation 185 Randomized Usual Care Group 180 Randomized Intervention Group Complete 6-month assessment: 144 Complete 6-month assessment: 128 Complete 12-month assessment: 142 Complete 12-month assessment: 113 Follow-Up Complete 18-month assessment: 130 Complete 24-month assessment: 166 a Non-English or Spanish speakers b Chronic use of medications likely to cause weight gain or prevent weight loss c Participants excluded due to a serious medical condition or psychiatric condition Complete 18-month assessment: 112 Page1of2 Complete 24-month assessment: 149 Figure 1

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4 atclinicc begancalls CallCenter Figure 2. atclinicb 1strandomization self+referral Providerand PTstaffhired 4short+term Weekly number of randomized participants with implementation date of recruitment strategies Passive approval firstmailing 10 Callr eplycard servicepurchased Onlinesearch Firstnewspaper ad strandomization Page1of1 Figure 2

5 Additional files provided with this submission: Additional file 1: BMC_Table 2.docx, 14K